Gupta 2000b.
Methods | RCT Study aim clearly defined: yes Blinded assessor of primary outcome: not stated Double blind study; yes Participants comparable at baseline for age: yes Sex: yes Duration of complaint: yes Inclusion and exclusion criteria specified: yes Interventions well described: yes Assessment of compliance: not stated Intention to treat analysis: yes A Priori sample size calculation: not stated Fungi identified: yes Distribution of species between groups: yes Adverse events reported: yes Number of drop outs stated: yes | |
Participants | Total evaluable sample size: 237 Exclusion criteria: white superficial or proximal subungual onychomycosis. Nail dystrophy. Infection which led to epinychium, antifungal therapy 24 weeks prior to study. Treatment setting; Multicentre studies USA | |
Interventions | a. Ciclopirox nail lacquer 8% solution Duration: 48 weeks Frequency: applied once daily b. Placebo solution Duration: 48 weeks Frequency: applied once daily: | |
Outcomes | Primary outcome: cure
Secondary Outcomes: Planimetric measurements % affected nail, Global evaluation score 0=cured, 1=excellent improvement, 2=moderate improvement; 3=slight improvement; 4= no change.
Adverse events: 10 (9%) group a,
7 (6%) group b. Data not presented |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |